NCT07027618

Brief Summary

This study aims to evaluate the effectiveness of an artificial intelligence (AI)-based software in personalizing high-quality end-of-life care for elderly patients. As the elderly population grows, providing tailored and quality care during the final stages of life becomes increasingly important. This AI software continuously monitors vital signs and behaviors through wearable sensors, offers smart medication reminders, alerts the care team to potential risks, and provides personalized care plans along with psychological and social support. The study is designed as a randomized controlled trial comparing two groups: one receiving standard end-of-life care and the other using the AI software. Key outcomes include improving quality of life, reducing adverse events like falls and emergency hospitalizations, increasing patient and family satisfaction, improving medication management, and reducing caregiver burden. Data will be collected over six months to assess these effects. The results will help determine whether AI technology can enhance end-of-life care for seniors and support families and healthcare providers.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jul 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jul 2025Sep 2026

First Submitted

Initial submission to the registry

June 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life Score

    Assessed using a validated instrument such as the Quality of Life at the End of Life (QUAL-E) scale to measure overall well-being, comfort, and satisfaction with care during end-of-life.

    Up to 3 months after intervention start

Study Arms (2)

AI-based Personalized End-of-Life Care

EXPERIMENTAL

Participants in this group will receive personalized end-of-life care supported by an AI-based software. The software monitors vital signs and behavior through wearable sensors, provides intelligent medication reminders, issues preventive alerts to the care team, delivers personalized care plans, and offers psychological and social support through communication features.

Behavioral: AI-based Software for Personalized End-of-Life Care

Standard End-of-Life Care

ACTIVE COMPARATOR

Participants in this group will receive standard end-of-life care without the use of the AI-based software. Care is provided according to usual clinical practices and guidelines.

Behavioral: AI-based Software for Personalized End-of-Life Care

Interventions

This intervention involves the use of an AI-powered software system designed to personalize end-of-life care for elderly patients. The software continuously monitors vital signs and behavior through wearable sensors, sends smart medication reminders, issues preventive alerts to care providers, delivers customized care plans, and provides psychological and social support through communication features.

AI-based Personalized End-of-Life CareStandard End-of-Life Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 60 years
  • Clinical diagnosis of being in the end-of-life stage, based on criteria such as the Karnofsky Performance Scale or Palliative Performance Scale
  • Informed consent obtained from the participant or legal representative
  • Ability to use technology independently or with support provided by the research team
  • Access to necessary equipment for the intervention (e.g., wearable sensors, smartphone/tablet)

You may not qualify if:

  • Presence of severe cognitive impairment preventing software use
  • Voluntary withdrawal from the study at any stage
  • Critical medical deterioration or death during the study
  • Poor adherence or insufficient engagement with the intervention software in the intervention group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: an intervention group receiving AI-based palliative care through a personalized software system, and a control group receiving standard end-of-life care without the AI intervention. Randomization will be conducted using block randomization to ensure balance in baseline characteristics. Although the study is open-label, outcome assessors will be blinded to group assignments to minimize assessment bias.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 18, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 18, 2025

Record last verified: 2025-06